Clinical Trial: Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Investigator-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, USP 10 mcg and Vagifem® (Estradiol
Brief Summary: The purpose of this study is to compare the safety and efficacy of generic Estradiol Vaginal Inserts, USP 10 mcg to the reference product Vagifem® 10 mcg and to determined whether the efficacy of each of the 2 active treatments is superior to that of the placebo.
Detailed Summary:
Sponsor: Amneal Pharmaceuticals, LLC
Current Primary Outcome: Responders [ Time Frame: Day 15 (1 day after the administration of the 14th dose of study treatment) ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Treatment Success [ Time Frame: Day 15 ]
Original Secondary Outcome: Same as current
Information By: Amneal Pharmaceuticals, LLC
Dates:
Date Received: January 28, 2013
Date Started: March 2012
Date Completion:
Last Updated: June 25, 2014
Last Verified: June 2014